According to the ICH E6 (R2) Step 4 version from November 9th 2016 “In the event of any conflict between the E6(R1) text and the E6(R2) addendum text, the E6(R2) addendum text should take priority” this means that now is more important than ever to understand and evaluate how the new updates affect the way research is conducted. In this session we will take an in depth look to the addendum to section 5.18.3 Extent and Nature of Monitoring in which remote monitoring conduct and responsibilities are addressed and clarified.

This session will focus on:

Identifying various types of remote monitoring with and without technology system leverage and integration

Understanding and clarifying many of the updates included in this revision which may affect your role and systems and strategies to adopt these changes.